The present invention relates to novel and improved apparatus and methods for percutaneous endoscopic gastrostomy. Particularly, the present invention relates to a kit containing various devices used in the gastrostomy apparatus and technique hereof, to the devices per se and to the technique itself.
Percutaneous endoscopic gastrostomy (PEG) was recently introduced as an alternative to surgically created feeding gastrostomy for nutritional support for the ill. The purpose of both techniques is to provide long-term tube access in those individuals unable to take oral nutrition, particularly for feeding directly across the abdominal and gastric walls into the stomach. Despite its relatively recent introduction, PEG has gained wide acceptance as a safe, time-tested and well-recognized method which avoids general anesthesia and laparotomy, allows earlier use of the feeding tube and reduces overall costs.
Currently, there are three variations of the PEG technique, known generally as the "Pull," "Push," and "Introducer" techniques. In all of these methods, as well as the method of the present invention, the patient is similarly prepared. For example, the patient is fasted for at least eight hours, prophylactic antibiotics are given and, with the patient in the supine position, the abdomen is prepared and local sedation is given. These preparatory procedures are conventional and need not be described in detail. In the "Pull" method, an endoscope is inserted into the patient's mouth and passed through the esophagus into the stomach. After distension of the stomach by inflation, the incision site is identified and an incision is made. A cannula, with an outer sheath, is inserted through the incision across the abdominal and gastric walls and into the snare loop on the endoscope end within the stomach. By grasping the cannula, the needle may be removed and a suture is passed through the cannula into the stomach. The endoscopic snare then grasps the suture, the cannula is released, and the endoscope and suture are withdrawn through the esophagus and mouth of the patient. A gastrostomy tube is then secured to the suture end and is pulled retrograde into the esophagus and stomach, emerging through the abdominal wall. When the head or retention device on the gastrostomy tube engages the gastric wall under observation by the reinserted endoscope, an outer retention device is applied to the gastrostomy tube to hold the gastric and abdominal walls in close contact. After a sufficient waiting period, the patient may then be fed through the gastrostomy tube.
In the "Push" technique, the patient is similarly prepared and the incision is made. However, instead of a suture, a flexible wire is passed through the cannula. The endoscopic snare grasps the wire and the endoscope and wire are pulled out the patient's mouth. The gastrostomy tube is then applied to and about the wire with its tapered end first. The guide wire is held taut as the gastrostomy tube is pushed over the guide wire, through the patient's mouth and esophagus, into the stomach and out the abdominal wall. When the retention device on the end of the gastrostomy tube is correctly positioned under endoscopic observation, the guide wire is removed and the outer retention device applied, whereby the patient may be fed in due course.
In the "Introducer" technique, a needle is inserted into the stomach through the incision and a guide wire is passed through the needle lumen. After the needle is removed, an "Introducer" with a peel-away sheath is passed over the guide wire into the stomach. The "Introducer" is then removed and a catheter is inserted through the sheath, the catheter having a Foley balloon at its end which is then inflated to retain the catheter in place. The sheath is then peeled away, leaving only the catheter in the stomach. After the outer retention device is applied, the patient may be fed in due course.
In accordance with the present invention, there is provided apparatus, for example, in the form of a "PEG" kit, and a technique for PEG which, as explained below, has various advantages over and addresses several of the shortcomings of each of the previously described "Pull," "Push" and "Introducer" PEG techniques. In the present invention, the apparatus essentially comprises a sleeve tube and a gastrostomy tube specifically adapted for use with one another and with other devices and implements which are currently used for the above-described conventional techniques. The sleeve comprises a tubing, preferably formed of plastic, having a thickness sufficient only to maintain substantial rigidity, while simultaneously being bendable and deformable. The interior diameter of the tube is sufficient to accommodate a gastrostomy feeding tube. The sleeve tube also has a length sufficient such that one end may exit the skin at the abdominal wall, while the other end remains outside the patient's mouth as the tube is being inserted. Additionally, the tube has a tapered end portion which gradually increases in diameter over approximately one-half of the length of the tube. The tube is provided adjacent the end opposite the tapered portion. Graduations to facilitate positioning the tube in the patient are provided. Further, an internal stabilizing loop is secured at the tip of the tapered end portion of the tube. The loop may comprise a soft plastic or thread bonded to the tube, having an elongated shape, and disposed with some degree of rigidity at a slight angle to the tube to preclude obstruction of the passage of the gastrostomy tube through the sleeve tube opening.
The gastrostomy tube for use with the present invention is preferably formed of a plastic material and has a diameter for reception within the sleeve tube. The gastrostomy tube has an integral expandable and retractable retention device at one end to facilitate its securement within the gastric wall. Such retention device may comprise an inflatable balloon or an expandable and retractable basket. With a balloon retention device, the external portion of the gastrostomy tube has a Y-configuration, with one branch for feeding purposes and the other tube for inflation and deflation of the balloon. Where a balloon is used, the balloon should have a configuration when inflated to enable a large area of contact between the balloon and the gastric wall. Also, either air or water inflation may be used. In the basket-type retention device, the basket includes a plurality of circumferentially spaced ribs secured at one end adjacent the inner end of the gastrostomy tube. The opposite end of the ribs is secured to a collar slidable on the gastrostomy tube such that, depending upon the position of the collar along the tube, the ribs are expanded radially outwardly or deflated radially inwardly to lie substantially parallel to and in contact with the gastrostomy tube end.
The PEG apparatus hereof, preferably supplied in a kit form, may also include a guide wire, needle catheter with stylette, an external retention device and a retrieval tube. The guide wire, catheter with stylette and external retention device may be conventional in construction. However, the retrieval tube hereof is used to facilitate removal of the gastrostomy tube from the stomach. The retrieval tube is particularly useful with the gastrostomy tube having the basket retention device. The retrieval tube is preferably provided with an end adapter specifically configured for cooperation with the collar on the basket, depending on the type of connection desired therebetween. For example, the collar on the end of the retrieval tube may comprise a plurality of circumferentially spaced hooks for engaging complementary hooks formed on the collar. Alternatively, the retrieval tube may have a screw thread for threaded engagement with the threaded collar on the basket retention device. In either case, when the retrieval tube is passed over the gastrostomy tube and connected to the collar, relative motion between the retrieval tube and gastrostomy tube enables the basket ribs to flatten along the side of the gastrostomy tube whereby the latter may be withdrawn.
To use the afore-described apparatus, the patient is prepared similarly as previously described as with respect to the "Push," "Pull," and "Introducer" techniques. With the endoscope passed through the mouth and esophagus into the stomach of the patient and the incision site located, a needle with internal stylette is passed through the incision into the stomach. The stylette is removed and the flexible guide wire is passed through the needle into the stomach and grasped with the endoscopic snare. The guide wire is then pulled with the endoscope through the esophagus and out the patient's mouth. The sleeve is disposed on the guide wire, tapered end first, and advanced along the guide wire through the mouth and esophagus into the stomach and out through the abdominal wall. With the endoscope reinserted into the stomach, the tapered end of the sleeve is pulled out through the abdominal wall to dilate the tract and locate the non-tapered end within the stomach short of the incision. The endoscopic snare is used to grasp the inner end of the sleeve to stabilize the sleeve during the remainder of the procedure. The guide wire is then removed and the sleeve is cut a distance, for example, several centimeters, above the skin to remove the tapered segment of the sleeve.
A gastrostomy tube is inserted into the stomach through the sleeve under endoscopic observation. To facilitate insertion, the adjoining walls of the gastrostomy tube and the sleeve may be lubricated. Also, a removable stiffening wire or rod may be used in the gastrostomy tube to facilitate its passage through the sleeve. Once the end of the gastrostomy tube is located within the stomach, the internal retention device is inflated or expanded and fixed in position. The sleeve is now withdrawn over the gastrostomy tube and removed by known techniques. Alternatively, the sleeve could be left in place over the external portion of the gastrostomy tube and later removed at the time of the first replacement of the gastrostomy tube. An outer retention device is then applied to the gastrostomy tube and the gastrostomy tube is secured in place.
To remove the gastrostomy tube, the balloon or basket internal retention device is deflated or contracted by external manipulation of the gastrostomy tube. For example, the balloon may be vented. To contract the basket retention device, a retrieval tube may be disposed about the gastrostomy tube and connected by either a snap-fit or threaded fit with the collar on the basket. When connected, relative movement of the retrieval tube and the gastrostomy tube enables the basket ribs to lie flat against the gastrostomy tube and the latter to be withdrawn from the ostomy tract. Reinsertion of a gastrostomy tube after the ostomy tract has matured is accomplished by inserting the new gastrostomy tube through the ostomy tract with the internal retention devices flattened or deflated along the gastrostomy tube. Thereafter, when the inner end of the gastrostomy tube is properly located, the balloon is inflated or the basket is expanded to retain the tube in the mature ostomy tract.
Various advantages are obtained when using the technique of the present invention. By using the unique internally delivered dilating tapered sleeve to dilate the tract as the sleeve is passed from the inside of the stomach out through the abdomen, optimum direction of force is maintained during the dilation period. The pressure of the tube dilating the tract in this direction maintains the desired apposition of the stomach and abdominal walls rather than tending to separate those walls as in other techniques, for example, the "Introducer" technique described above. The external placement of the gastrostomy tube by use of the internally delivered dilating sheath enables both deployment and retraction of the internal retention device from the outside, subsequent to removal, and replacement of the gastrostomy tube without the need of endoscopy. In the "Pull" and "Push" techniques, removal of the initially disposed gastrostomy tube requires endoscopic removal of the internal retention device. This increases the overall cost of maintaining tube feeding but also exposes the patient to the risk of an additional procedure, as well as the risk of extraction of the internal retention device through the upper airway.
Additionally, because the internal retention device of the present invention does not have to traverse the mouth and esophagus to be positioned in the stomach, the present apparatus and technique is usable in a greater number of patients, i.e., those patients exhibiting narrowing in those areas than is currently possible with the "Push" and "Pull" techniques. Also, the basket-type retention device, with the screw-lock or snap-lock lessens the chance of inadvertent retraction and removal of the gastrostomy tube.
The present invention may also include a jejunostomy tube which is basically similar to the gastrostomy tube described above, except that it has a longer distal end for placement in the small bowel for feeding. The distal end is weighted to facilitate passage of the tube into the jejunum and maintain the position of the tube in the small bowel. Preferably, the jejunostomy tube has an internal stiffening wire to aid in tube tip placement. An alternate form of jejunostomy tube may be provided with a second internal tube, either concentrically or radially spaced from the feeding tube, wherein the second tube has ports or openings in the stomach allowing for simultaneous gastric suction for decompression of the stomach while providing small bowel feedings.
The method of insertion of the jejunostomy tube is similar to that for the gastrostomy tube as describe above to the point of expansion of the internal retention device. To facilitate proper placement of the jejunostomy tube, the distal tube tip is provided with a small thread loop. An endoscopic snare or forceps are used to grasp the thread loop, which is then advanced into the small bowel as far as possible. The thread loop is then released and the endoscope withdrawn. The stiffening wire is also removed. The withdrawal procedure for the jejunostomy tube is identical to that for the gastrostomy tube described above.
Preferably, the apparatus described above for percutaneous endoscopic gastrostomy is provided in kit form. The apparatus necessary for inclusion in the kit include the sleeve tube, needle cannula with stylette, guide wire, retrieval tube and stiffening rod (for basket-type retention), gastrostomy tube (basket or balloon-type) and an external retention device. One or more of the following items may be included in the kit as desired, an inflation syringe (for balloon-type), scalpel, local anesthetic, a syringe and needle for local anesthetic, gauze, sterile drape, cleansing solution and scissors. A jejunostomy tube insertion kit would include those essential items described above for the gastrostomy insertion kit, except that the jejunostomy tube would be included instead of the gastrostomy tube. The present invention also encompasses a replacement gastrostomy tube kit. This kit would include a gastrostomy tube and a retrieval tube and stiffener (basket-type). If a balloon-type retention device is used, an inflation syringe would be included in the kit in lieu of the stiffener useful for the basket-type retention device. Additionally, a replacement jejunostomy tube kit may be provided similarly as described above with respect to the replacement gastrostomy tube kit. In the jejunostomy tube kit, however, the kit would include the jejunostomy tube in lieu of the gastrostomy tube.
In a preferred embodiment according to the present invention, there is provided a procedure for percutaneous endoscopic gastrostomy using a guide wire, a sleeve having a tapered end and a gastrostomy tube having a retention device adjacent one end, comprising the steps of (a) passing an endoscope through a patient's mouth and esophagus and into the patient's stomach, (b) introducing the guide wire through the patient's abdominal and gastric walls and into the patient's stomach, (c) grasping a portion of the guide wire within the stomach, (d) pulling the endoscope and guide wire from the stomach out the patient's mouth, (e) passing the sleeve, tapered end first, over the wire through the patient's mouth, esophagus and stomach and out through the abdominal and gastric walls, leaving terminal portions of the sleeve on opposite sides of the abdominal and gastric walls, (f) withdrawing the guide wire from the sleeve, (g) inserting the gastrostomy tube through the sleeve to locate the end thereof carrying the retention device within the stomach and (h) activating the retention device to retain the gastrostomy tube within the stomach.
In a further preferred embodiment according to the present invention, there is provided apparatus for performing percutaneous endoscopic gastrostomy comprising an elongated flexible guide wire having a length sufficient to extend from a location outside the abdominal wall of a patient through the patient's stomach and esophagus and out the patient's mouth, an elongated sleeve having a tapered end portion and an internal diameter sized to enable slidable movement thereof along the guide wire, the sleeve having a length sufficient to extend from a location outside the abdominal wall of a patient through the patient's stomach and esophagus and out the patient's mouth and a gastrostomy tube for reception within the sleeve and having a retention device adjacent an end portion thereof for retaining the gastrostomy tube within the patient's stomach in position for feeding.
In a further preferred embodiment according to the present invention, there is provided a percutaneous endoscopic kit comprising a container, a needle cannula with stylette in the container, and an elongated flexible guide wire in the container. The wire has a length sufficient to extend from a location outside the abdominal wall of a patient through the patient's stomach and esophagus and out the patient's mouth. Also provided is an elongated sleeve in the container, having a tapered end portion and an internal diameter sized to enable slidable movement thereof along the guide wire, the sleeve having a length sufficient to extend from a location outside the abdominal wall of a patient through the patient's stomach and esophagus and out the patient's mouth. One of a gastrostomy tube or jejunostomy tube for reception within the sleeve and a retention device for location adjacent an end portion of one tube for retaining one tube in position for feeding are also provided in the container.
Accordingly, it is a primary object of the present invention to provide novel and improved apparatus and methods for percutaneous endoscopic gastrostomy having various advantages in concept, construction, mode of use and result in comparison with prior percutaneous endoscopic gastrostomy apparatus and techniques.
These and further objects and advantages of the present invention will become more apparent upon reference to the following specification, appended claims and drawings.